Nazione: Stati Uniti
Lingua: inglese
Fonte: NLM (National Library of Medicine)
KETOPROFEN (UNII: 90Y4QC304K) (KETOPROFEN - UNII:90Y4QC304K)
Aidarex Pharmaceuticals LLC
ORAL
PRESCRIPTION DRUG
Carefully consider the potential benefits and risks of ketoprofen capsules USP and other treatment options before deciding to use ketoprofen capsules USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Ketoprofen capsules USP are indicated for the management of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ketoprofen capsules USP are indicated for the management of pain. Ketoprofen capsules USP are also indicated for treatment of primary dysmenorrhea. Ketoprofen capsules are contraindicated in patients who have shown hypersensitivity to ketoprofen. Ketoprofen capsules should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic reactions to ketoprofen have been reported in such patients (see WARNINGS , Anaphylactoid Reactions and PRECAUTIONS , Preexisting Asthma ). Ketoprofen capsules are contraindicate
Ketoprofen capsules USP are available as follows: 50 mg: Blue cap and light blue body, imprinted “93” over "3193" on the cap and on the body. Keep tightly closed. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
Abbreviated New Drug Application
Aidarex Pharmaceuticals LLC ---------- Medication Guide for Nonsteroidal Anti- inflammatory Drugs (NSAIDs) What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)? NSAIDs can cause serious side effects, including: • •Increased risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase: • owith increasing doses of NSAIDs • owith longer use of NSAIDs • Do not take NSAIDs right before or after a heart surgery called a “coronary artery bypass graft (CABG).” • Avoid taking NSAIDs after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack. • •Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines: • oanytime during use • owithout warning symptoms • othat may cause death • The risk of getting an ulcer or bleeding increases with: • opast history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs • otaking medicines called “corticosteroids”, “anticoagulants”, “SSRIs”, or “SNRIs” • oincreasing doses of NSAIDs • oolder age • olonger use of NSAIDs • opoor health • osmoking • oadvanced liver disease • odrinking alcohol • obleeding problems NSAIDs should only be used: • oexactly as prescribed • oat the lowest dose possible for your treatment • ofor the shortest time needed What are NSAIDs? NSAIDs are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as different types of arthritis, menstrual cramps, and other types of short-term pain. Who should not take NSAIDs? Do not take NSAIDs: • •if you have had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAIDs. • •right before or after heart bypass surgery. Before taking NSAIDs, tell your Leggi il documento completo
KETOPROFEN- KETOPROFEN CAPSULE AIDAREX PHARMACEUTICALS LLC ---------- KETOPROFEN CAPSULES USP 3193 3195 RX ONLY CARDIOVASCULAR THROMBOTIC EVENTS •Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use (see WARNINGSand PRECAUTIONS). •Ketoprofen capsules are contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see CONTRAINDICATIONS and WARNINGS). GASTROINTESTINAL RISK •NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal (GI) events (see WARNINGS). DESCRIPTION Ketoprofen capsules USP are a non-steroidal anti-inflammatory drug. The chemical name for ketoprofen, USP is 2-(3-benzoylphenyl)-propionic acid with the following structural formula: C H O M.W. 254.29 It has a pKa of 5.94 in methanol: water (3:1) and an n-octanol: water partition coefficient of 0.97 (buffer pH 7.4). Ketoprofen, USP is a white or practically white, crystalline powder, melting at about 95°C. It is freely soluble in ethanol, chloroform, acetone, ether and soluble in benzene and strong alkali, but practically insoluble in water at 20°C. Ketoprofen capsules USP contain 50 mg or 75 mg of ketoprofen, USP for oral administration. INACTIVE INGREDIENTS Drug Product Lactose, magnesium stearate, and sodium starch glycolate. 16 14 3 Capsule Shell Constituents Gelatin, printing ink, sodium lauryl sulfate, titanium dioxide, D&C Red #28, and FD&C Blue #1. CLINICAL PHARMACOLOGY Ketoprofen is a non-steroidal anti-inflammatory drug with analgesic and antipyretic properties. The anti-inflammatory, analgesic and antipyretic properties of ketoprofen have been demonstrated in cl Leggi il documento completo